ACUTE LYMPHOBLASTIC LEUKEMIA STUDY GROUP OF INDIA ALL SGI Dr

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ACUTE LYMPHOBLASTIC LEUKEMIASTUDY GROUP OF
INDIAALL SGI

• Dr Suresh Advani
• Mumbai , INDIA.

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ALLMAGNITUDE OF PROBLEM IN INDIA

• Population 1 Billion
• Pop. lt 18 yrs 40
• New cases/ yr 8000
• Per capita GNP US 350
• National Priority ID Nutritional
  Diseases
• 1 in 7 people in the world, Indian!

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ALL IN INDIA FACTS

• 8000 new cases/yrlt 1000 adequately Rxed
• Mostly Morphological diagnosis
• No National data available
• Tough gt 70 cured in West, in India except in
  major centres results still very poor.
• Cost of Rx 1500 affordability 70/2 5/5
• Access to Rx PCUs infrastructure
• Most are HR late presentation biology?
• Females under represented

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ALL IN INDIA - BACKGROUND

• Before 90s Survival rate of lt 30
• Rx not organized
• Criteria for protocol entry not well defined
• Diff. protocols used even in same Institution!
• 1st effort to organize ALL Rx was by
• Dr Ian Magrath The NCI initiative 1985
• ACI TMH AIIMS

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OAS 65.5
n688
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All IN INDIA NCI INITIATIVE

• Helped to
• organize Rx for ALL
• develop infrastructure
• Rx patients uniformly- inside/outside
• anticipate problems deal with them
• identify some prognostic factors
• The success with MCP 841 protocol at the National
  level has been the impetus to form the ALLSGI !

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ALLSGI FORMATION

• Jan 27, 2001 Pre ISMPO Hyderabad
• Why now?
• More trained Oncs Many trained with us
• PCUs increasing
• SIOP Initiative Training of Peds
• INCTR Initiative expertise, training, res.
• Better Communication Transport

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ALL SGI INITIAL OBJECTIVES

• To get organized
• To get used to data collection
• Identifying participating centers
• Try to develop infrastructure at participating
  centers (Dx Nursing BBMicrobiology)
• Chalk out short term objectives long term goals!

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ALL SGI FORMATION OF ZONES

• India is Big Country Many centers, Many Pts
• North Zone AIIMS, Delhi
• East Zone KMC, Calcutta
• South Zone ACI,Chennai
• West Zone TMH, Mumbai
• Central data collection Monitoring unit

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ALL SGIWhat Have We Achieved So Far

• -Data of gt2000 patients treated uniformly on a
  single protocol
• Publications from individual centres
• Publications of data as a group

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Event-Free Survival by Center
TMH
Percent Event Free Survival
AIIMS
CI
Years since start of therapy
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Risk Factors (EFS) Multivariate Analysis

• WBC at AIIMS and Mumbai (p0.0005 and 0.002
  respectively), not at CI
• But best risk group still lt 70 EFS
• No significant risk factors could be identified
  at Chennai nor in Pre B or Pre-T separately
• No very high or very low risk groups identifiable
  at all three centers
• Early response not studied

Extensive analysis performed by experienced NCI
statisticians
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Temporal Changes with Identical Protocol
1995-96
1989-90
Percent Event Free Survival
1991-92, 93-94
1986-87
TMH 2 yr intervals 101-163 patients per group
Years since start of therapy
A 1986-87 B 1988-90 C 1991-92 D 1993-94
E 1995-96 F 1997
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Translocations in ALL
Childhood , USA
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ALL SGI TO WRITE GRANTS

• Grant from Lady Ratan Tata Trust For Developing
  the Cooperative Group
• To Write Grants For
• Epidemological studies Clinical Molecular
• Clinical studies
• Lab studies Pathogenesis, Mol. Biology
• Preventive Aspects

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ALL SGI ALL TREATMENT

• Develop infrastructure
• Rx data initially only from limited centers
• To continue established protocol (e.g. MCP 841)
  at these centers
• Investigational protocol(e.g. MCP 943) only at
  zonal centers
• Highest quality of information must be assured
  Diag, data collection, data analysis
• Once group established, only then to think about
  ALL National Protocol- keeping in mind simplicity
  cost!

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ALL SGI LONG TERM GOALS RESEARCH INITIATIVES

• Is ALL in India Biologically different?
• Std risk factors do not show diff in outcome
• many remission deaths
• Delays in Rx hepatitis, toxicity,etc
• Socioeconomic risk profile
• Toxicity profile
• Nutritional status
• Pharmacokinetics, Pharmacogenomics
• Difference in Leukemic cell or Patient ??

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ALL FUTURE PLANS